|
Model Number 8015 |
Device Problems
Failure to Power Up (1476); Failure to Read Input Signal (1581)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 08/18/2023 |
Event Type
malfunction
|
Manufacturer Narrative
|
A device history record review is performed on each device reported in a mdr reportable event along with other methods of investigation as coded in section h6 of this mdr report.Per 803.52(f)(11)(iii), the information provided was obtained from servicing activities performed on the device.There were no additional details obtainable or provided at the time of service.H3 other text : see manufacturer narrative.
|
|
Event Description
|
It was reported that the device had no power, replaced keypad and main board, still no power.There was no patient involvement.
|
|
Event Description
|
It was reported that the device had no power, replaced keypad and main board, still no power.There was no patient involvement.
|
|
Manufacturer Narrative
|
Correction: annex b: b21 annex c: c21 annex d: d16 additional information: device available for eval?, returned to manufacturer on, device return to manuf.?, device eval by manufacturer?, remedial action required, remedial action #, annex a: a1301.Annex b: b01.Annex c: c0601.Annex d: d01.Annex g: g0204002.
|
|
Search Alerts/Recalls
|
|
|